Anticoagulation Management in Complex Cardiac Surgery

Phase 4

Completed

• Conditions: Extracorporeal Circulation
• Interventions: Other: Activated Clotting Time; Other: Activated Clotting Time measurements combined with heparin concentration monitoring

• Registration Number: NCT05944107
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief Summary

The goal of this clinical trial is to compare the anticoagulation management with or without heparin concentration level guidance, in patients undergoing valve or complex cardiac surgery during cardiopulmonary bypass using closed, coated circuits. The main questions it aims to answer are:

* initial heparin bolus, subsequent supplementary doses and total heparin variance among groups.

* protamine dose among groups.

Participants are adult patients scheduled for valve or complex cardiac surgery. They are randomised to either Activated Clotting Time guided management alone or combined with heparin level concentration monitoring.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-02-20
• Study First Submitted: 2023-06-24
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-11
• Last Update Submitted: 2023-07-12
• Study First Posted: 2023-07-13
• Last Update Posted: 2023-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• elective procedures
• cardiac surgery, except for Coronary Artery Bypass Grafting
• Cardiopulmonary bypass under Minimally Invasive Extracorporeal Circulation

Exclusion Criteria

• known allergy to heparin or protamine
• hematological disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Activated Clotting Time (ACT)	Activated Clotting Time	In this group, only ACT measurements and fixed doses of heparin and protamine are administered. ACT is measured using the ACT Plus device (Medtronic, MN, USA). Heparin formulation administered is HEPARIN/LEO INJ.SOL 25000IU/5ML. Protamine formulation administered is PROTAMINE SULPHATE/LEO PHARMA 10mg/ml
Heparin Concentration (HC)	Activated Clotting Time measurements combined with heparin concentration monitoring	In this group, the Hepcon HMS Plus (Medtronic, MN, USA) is used to perform heparin concentration calculations and test each patient's individual response to heparin. Specifically tests performed were: * Heparin Dose Response test * Heparin Assay test

Primary Outcome Measures

Name	Time	Method
Heparin dose	Total dose after cardiopulmonary bypass	Heparin dose, IU
Protamine dose	Total dose after cardiopulmonary bypass	Protamine dose, mg

Secondary Outcome Measures

Name	Time	Method
Platelet count	48 hours after surgery	Platelet count per mm\^3

Trial Locations

Locations (1)

AHEPA University Hospital, Aristotle University of Thessaloniki; 🇬🇷 Thessaloniki, Greece